Patent application title: Films Comprising a Plurality of Polymers

Abstract:

Films are disclosed that comprise a first polymer and a second polymer
having a solubility temperature lower than that of the first polymer;
wherein the breaking strength of the film is greater than about 750 psi
(5,171 kPa). Also disclosed are compositions comprising such films that
are useful as oral care, personal care or home care compositions. Methods
of using such compositions are also disclosed.

Claims:

1. A first comprising:(a) a first polymer; and(b) a second polymer having
a solubility temperature lower than that of the first polymer;wherein the
breaking strength of the film is greater than about 750 psi (5,171 kPa).

2. The film according to claim 1, wherein the breaking strength of the
film is about 750 psi (5,171 kPa) to about 5,000 psi (34,470 kPa).

3. The film according to claim 1, wherein at least one of the first
polymer or second polymer is chosen from cellulose ethers, methacrylates,
polyvinylpyrollidone, polyethylene oxides, polypropylene oxides and
mixtures and copolymers thereof.

4. The film according to claim 1, wherein at lease one of the first
polymer or second polymer is a water soluble polymer.

5. The film according to claim 1, wherein the first polymer is a cellulose
ether.

6. The film according to claim 5, wherein the first polymer is
hydroxypropylmethylcellulose (HPMC) or hydroxypropyl cellulose (HPC).

7. The film according to claim 1, wherein the first polymer has an
incipient gelation temperature of about 45 to about 55 degrees C. at a
10% weight concentration, and wherein the second polymer has an incipient
gelation temperature of about 25 to about 35 degrees C. at a 10% weight
concentration.

8. The film according to claim 1, wherein the film has a substantially
lamellar structure.

9. The film according to claim 1, wherein the first polymer has a
solubility temperature greater than about 100 degrees F. (37.8.degree.
C.), and the second polymer has a solubility temperature of less than
about 100 degrees F. (37.8.degree. C.).

10. The film according to claim 1, wherein the first polymer has a
solubility temperature about 105 degrees F. (40.6.degree. C.) to about
170 degrees F. (76.7.degree. C.), and the second polymer has a solubility
temperature of about 80 degrees F. (26.7.degree. C.) to about 140 degrees
F. (60.0.degree. C.).

11. A composition comprising a film in a carrier, wherein the film
comprises a first polymer and a second polymer having a lower solubility
temperature than the first polymer, and wherein the breaking strength of
the film is greater than about 750 psi (5,171 kPa).

12. The composition according to claim 1, wherein at least one of the
first water soluble polymer or second water soluble polymer is chosen
from cellulose ethers, methacrylates, polyvinylpyrollidone, polyethylene
oxides, polypropylene oxides and mixtures and copolymers thereof.

13. The composition according to claim 12, wherein the first polymer is
hydroxypropylmethylcellulose (HPMC) and the second polymer is
methylcellulose (MC).

15. The composition according to claim 11, in the form of a dentifrice.

16. The composition according to claim 11, wherein the ratio of the first
polymer to the second polymer is about 1:3 to about 3:1.

17. A film comprising:(a) about 5 to about 50% of a cellulosic composition
chosen from hydroxypropylmethylcellulose or hydropropylcellulose based on
dry weight; and(b) about 5 to about 50% of methyl cellulose based on dry
weight; wherein the breaking strength of the film is greater than about
750 psi (5,171 kPa).

18. The film of claim 17, comprising:(a) about 10 to about 40%
hydroxypropylmethylcellulose or hydroxypropylcellulose based on dry
weight; and(b) about 10 to about 40% of methyl cellulose based on dry
weight.

19. A method for administering an active material comprising applying a
film comprising a first polymer and a second polymer having a lower
solubility temperature than the first polymer to a human or animal
subject, wherein the film comprises the active material, and wherein the
ratio of the first polymer to the second polymer is about 1:3 to about
3:1.

20. The method according to claim 19, comprising applying the composition
to the teeth or oral surfaces of a subject.

21. A method for improving stability of a film, comprising the steps of
forming a film by combining a first polymer and a second polymer, wherein
the second polymer has a solubility temperature lower than that of the
first polymer, to provide a film having a higher breaking strength than a
film comprising only the first water soluble polymer.

22. A method for maintaining the systemic health of a mammal, comprising
the steps of administering to the mammal a composition comprising a film
according to claim 14.

23. A composition comprising a film according to claim 1, wherein the
composition is in the form of a soap, a lotion, a body wash, a bath gel,
a shampoo, a conditioner, a deodorant, an antiperspirant, a fragrance, a
perfume or a cosmetic.

24. A composition comprising a film according to claim 1, wherein the
composition is in the form of a foaming agent, surfactant, cleansing
agent, bleach, detergent, or fabric softening agent.

Description:

BACKGROUND OF THE INVENTION

[0001]The present invention is related to films comprising polymers,
compositions comprising such films, and methods for improving the
delivery of an active agent to a surface.

[0002]Compositions such as oral care compositions, personal care
compositions and home care compositions are used for a wide variety of
purposes, including the enhancement of personal health, hygiene and
appearance, preventing or treating a variety of diseases and other
conditions in mammals, and delivery of agents to household surfaces for
cleaning, disinfecting, imparting pleasant odors and other benefits. Such
compositions may contain films that have functional or active materials
contained therein, and that may be stored in a carrier or vehicle of the
product. Upon use, the films may degrade by chemical or physical
disruption, thereby releasing the active or functional material into the
surrounding environment. In this manner, the films provide an opportunity
for localized release of a high concentration of active materials near a
target surface.

[0003]However, there is an ongoing need for improved films having
beneficial properties such as increased stability and optimal adhesion to
the target surface, as well as methods for improving the stability of
oral, personal and home care compositions comprising films to deliver
active agents.

SUMMARY OF THE INVENTION

[0004]The present invention provides, in certain embodiments, a film
comprising: [0005](a) a first polymer; and [0006](b) a second polymer
having a solubility temperature lower than that of the first
polymer;wherein the breaking strength of the film is greater than about
750 psi (5,171 kPa). The present invention provides, in other
embodiments, methods of delivering a film comprising a first polymer, a
second polymer having a solubility temperature lower than that of the
first polymer, and a breaking strength of greater than about 750 psi
(5,171 kPa) to a surface, comprising administering a composition
comprising the film to the surface. In various embodiments, the breaking
strength of the film is greater than about 1,000 psi (6,894 kPa), 1,100
psi (7,584 kPa), greater than about 1,250 psi (8,618 kPa) or greater than
about 1,500 psi (10,342 kPa). In various embodiments, the breaking
strength of the film is about 750 psi (5,171 kPa) to about 5,000 psi
(34,470 kPa) or about 750 psi (5,171 kPa) to about 2,900 psi (19,995
kPa).

[0007]In various embodiments, the present invention provides a film
comprising:

[0008](a) about 5 to about 50% hydroxypropylmethylcellulose or
hydroxypropylcellulose (or mixtures thereof) based on dry weight; and

[0009](b) about 5 to about 50% of methyl cellulose based on dry weight;

wherein the breaking strength of the film is greater than about 750 psi
(5,171 kPa).

[0010]In various embodiments, the present inventions are directed to a
method for administering an active material comprising applying a film
comprising a first polymer and a second polymer having a lower solubility
temperature than the first polymer to a human or animal subject, wherein
the film comprises the active material, and wherein the ratio of the
first polymer to the second polymer is about 1:3 to about 3:1.

[0011]In various embodiments, such methods further comprise disrupting the
film after its application to the desired surface. In various
embodiments, the compositions comprise a film comprising one or more
functional or active materials that are released at different times or
concurrently in a controlled release manner, such as by sustained or
delayed release.

[0012]In various embodiments, the present invention further provides
methods of improving the stability of an oral care formulation,
comprising the steps of forming a film by combining a first polymer and a
second polymer, wherein the second polymer has a solubility temperature
lower than that of the first polymer.

DETAILED DESCRIPTION OF THE INVENTION

[0013]As used herein, ranges are a shorthand for describing each and every
value within a range, including endpoints. All references cited in the
present disclosure are hereby incorporated by reference in their
entirety. Where there is a conflict between a definition in the present
disclosure and that of a cited reference, the present disclosure
controls.

[0014]The present invention provides compositions comprising films having
desirable physical properties. For example, it has been found that
certain oral care compositions can be enhanced by the addition of films
that have impregnated therein active ingredients. See, e.g., U.S. Pat.
No. 6,669,929 to Boyd et al. However, there is still an ongoing need for
improved stability and efficacy in such compositions, as well as the
achievement of sustained release of active agents. Other problems remain
with regard to incompatability of various components in a formulation.
For example, organic acids have been found to make some oral care
compositions unstable by impacting the solubility or precipitation of
polymers, thus leading to overly soluble (i.e., unstable) films. This
kind of disadvantage can lead to undesirable instability problems in all
realms of consumer products, as organic acids such as citric acid,
gluconic acid and other polymeric acids and polyacryclic acids are
commonly found oral care, personal care and home care applications.

[0015]The compositions and methods of the present invention provide
superior ability to release active agents, based on the discovery that
providing a film with at least two polymers having different solubility
temperatures results in films that are able to provide a desirable
ongoing rate of release of active agent. The compositions of the present
invention are advantageous in that they exhibit benefits such as enhanced
stability and delivery profiles for oral care, personal care and home
care compositions comprising films.

[0016]In certain embodiments, the present invention is directed to a film
comprising:

[0017](a) a first polymer; and

[0018](b) a polymer having a solubility temperature lower than that of the
first polymer;

wherein the breaking strength of the film is greater than about 750 psi
(5,171 kPa). As used herein, the term "solubility temperature" refers to
the temperature at which a given water soluble polymer in its solid form
dissolves in a solvent. In the case of many cellulosic polymers such as
methylcellulose, hydroxypropyl methyl cellulose and hydroxypropyl
cellulose, the term "gelation temperature" may be used to indicate the
temperature above which such polymers are generally not soluble in water.

[0019]In certain embodiments, at least one of the first polymer or second
polymer may be a water soluble polymer, water dispersible polymer, or a
mixture thereof. Where at least one of the polymers is water soluble, it
need not be completely water soluble, so long as a solubility temperature
can be measured. In certain embodiments, at least one of the first
polymer or second polymer is a cellulosic polymer. In various
embodiments, at least one of the first polymer or second polymer is
hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), or
methylcellulose (MC). In various embodiments, the first polymer is
hydroxypropylmethylcellulose (HPMC) and the second polymer is
methylcellulose (MC).

[0020]In various embodiments, at least one of the water soluble polymers
can be chosen from polyvinylpyrrolidone, polyacrylic acid,
polymethylacrylic acid, carboxymethyl cellulose, polyvinylalkyl
ether-maleic acid copolymer (available under the trade name Gantrez), and
various naturally derived polymers, such as xanthan gum, locust bean gum,
chitosan and hyaluronic acid.

[0021]In the embodiments of the present invention, the solubility
temperature of the polymers can be determined according to the Solubility
Temperature Test, which is performed as follows:

The Solubility Temperature Test

[0022]The solubility temperature is defined for a single polymer, cast
into a film and cut into a 1 inch (2.54 cm) diameter circle at or above
40% by weight (see the Example for an illustrative single polymer film
formulation). Film compositions of 2 mils (0.051 mm) thickness are
prepared with a polymer. The Dissolution Time is measured--that is, the
time it takes a film to disperse in an 11 inch by 17 inch (28 cm×43
cm) pan filled to 1 inch (2.54 cm) deep with quiescent water, such that
the piece of polymer film is no larger than about 1/4 inch by about 1/4
inch (0.64 cm×0.64 cm). At higher water temperatures, the
Dissolution Time will increase for certain polymers (such as cellulose
ethers). The Solubility Temperature is the water temperature at which the
Dissolution Time of the film is first measured to be 15 minutes or
longer.

[0023]In various embodiments, the first polymer has a solubility
temperature greater than about 100 degrees F. (37.8° C.), about
100 degrees F. (37.8° C.) to about 200 degrees F. (93.3°
C.), and about 105 degrees F. (40.6° C.) to about 170 degrees F.
(76.7° C.). In various embodiments, the second polymer has a
solubility temperature of less than about 100 degrees F. (37.8°
C.), about 80 degrees F (26.7° C.) to about 140 degrees F.
(60.0° C.), or about 100 degrees F. (37.8° C. ) to about
150 degrees F. (65.6° C.).

[0024]In certain embodiments, the present invention provides compositions
comprising a film in a carrier, wherein said film comprises a mixture of
a first polymer and a second polymer having a solubility temperature that
is lower than that of the first polymer.

[0025]In certain embodiments, the film is suitable for use in an oral care
composition, a personal care composition (e.g., a hair care composition
or a skin care composition) or a home care composition. In various
embodiments, the film comprises a functional or active material may be
chosen from an oral care active, a personal care active or a home care
active.

Film:

[0026]The embodiments of the present are directed to films and
compositions that comprise a film. As referred to herein, a "film" is a
material that may have substantially lamellar structure, or alternatively
may have a substantially non-lamellar structure, e.g., a particle.

[0027]A "lamellar" structure has, or is capable of having, a size in one
or two dimensions (e.g., the x- or y-dimensions) that is substantially
greater than the thickness of the structure in a third dimension (e.g.,
the z-direction). Useful lamellar structures may include those that are
substantially planar, layered, or lamelliform. In various embodiments,
the lamellar structure may be substantially planar (having a size in both
the x- and y-dimensions that is substantially greater than the
z-direction) or non-planar. In various embodiments, the film may comprise
a substantially continuous surface that can appear as a substantially
flat surface, or may be deformed. The film can have any of a number of
shapes.

[0028]In contrast, in embodiments wherein the film is non-lamellar, it may
be a particle, having, for example, a spherical, spheroid, oblong, or
otherwise irregularly shaped and/or having uniform thickness, in contrast
to lamellar, form.

[0029]In the embodiments of the present invention, the film comprises at
least a first polymer and a second polymer. Useful polymers include water
soluble polymers, water dispersible polymers or mixtures thereof

[0030]In certain embodiments, at least one of the first polymer or second
polymer is a water soluble, breakable polymer that dissolves during use,
such as, for example, during the brushing of teeth, the application of a
composition to the skin or hair, or the application of a composition to a
household surface such as a hard surface or article of clothing (e.g.,
scrubbing or wiping). Such dissolution can occur as a result of, for
example, shearing and/or exposure to a solvent comprising a high
concentration of water (including saliva). In some embodiments, the
polymer is insoluble but breakable in water by being dispersible, i.e.,
the polymer breaks down into small fragments, for example, as a result of
shearing. In some embodiments, a film fragment can comprise a mixture of
film forming materials. Water soluble or water dispersible polymers that
may be useful for the present embodiments include cellulose ethers,
methacrylates, polyvinylpyrollidone, and mixtures thereof. In certain
embodiments, the first polymer is a cellulose ether, such as one chosen
from hydroxyalkyl cellulose polymers such as hydroxypropyl methyl
cellulose (HPMC), hydroxypropyl cellulose (HPC), methyl cellulose (MC),
carboxymethyl cellulose and mixtures thereof. For example, HPMC has an
incipient gelation temperature of about 45 to about 55 degrees C. at a
10% weight concentration, and MC has an incipient gelation temperature of
about 25 to about 35 degrees C. at a 10% weight concentration (Dow
Technical Handbook, "Methocel Cellulose Ethers," September 2002).

[0032]In certain embodiments, at least one of the first polymer or second
polymer is a hydroxyalkyl cellulose such as hydroxypropyl methyl
cellulose, hydroxyethylpropyl cellulose, hydroxybutyl methyl cellulose,
hydroxy propyl cellulose or carboxymethyl cellulose. In certain
embodiments, the first polymer is a low viscosity HPMC. When HPMC is used
as the film forming agent, it may have a viscosity in the range of about
1 to about 1000 mPas as determined as a 2% by weight aqueous solution of
the HPMC at 20° C. using a Ubbelohde tube viscometer. In certain
embodiments the HPMC has a viscosity of about 3 to about 500 mPas at
20° C. HPMC is available commercially, for example, from the Dow
Chemical Company under the trade designation Methocel, including as
Methocel E5LV, Methocel E50, and Methocel K100. Methocel ES LV is a USP
grade, low viscosity HPMC having 29.1% methoxyl groups and 9%
hydroxyproxyl group substitution, and is a white or off-white
free-flowing dry powder. As a 2 wt. % solution in water as measured with
a Ubbelohde tube viscometer, it has a viscosity of 5.1 mPas at 20°
C. In various embodiments, at least one of the first water soluble
polymer or second water soluble polymer is incorporated in the film
matrix in amounts ranging about 10 to about 80% by weight, about 20 to
about 75% by weight, or about 30 to about 60% by weight.

[0033]In various embodiments, the film disintegrates during use of the
composition. In some embodiments, the film releases the functional or
active material into the carrier. As referred to herein, "disintegrate"
refers to physical disruption of the film or fragment material, so as to
produce a film or film fragments of reduced size compared to the original
film. Such disruption may be through mechanical, chemical means, or a
combination thereof. The disintegration can result, for example, from
shearing, grinding, scrubbing (as with a brush or other implement), or
exposure to elevated temperatures or solvents such as water or saliva
during use; or from change in pH or breakdown through enzymes.

[0034]The film of the present invention optionally comprises materials
that affect the physical or functional characteristics of the film. Such
additional substances can be, for example, emulsifiers, plasticizers,
fillers, or texture modifiers. Fillers may include inert starch particles
and cellulose. Texture modifiers may include cold water swellable,
physically modified and pregelatenized starches, to increase the
stiffness of polymeric films.

Functional or Active Material:

[0035]The films of the present invention may comprise a functional or
active material. Additionally, in the embodiments of the present
invention directed to compositions comprising films, the compositions may
further comprise a functional or active material. As referred to herein,
the terms "functional material" or an "active material" are used
interchangeably, and refer to a material having a desired utility in the
oral, personal or home care area. In various embodiments, such utilities
may be therapeutic, cosmetic, aesthetic, decorative, cleansing,
disinfecting, bleaching, descaling, sensory or combinations thereof

[0036]The functional materials may be, for example, adsorbed to the
surface of the film, incorporated within the film or comprise one or more
coatings on the surface of the film. Certain embodiments may be directed
to oral care, personal care or home care compositions comprising one or
more of a first film fragment having a first functional material, and one
or more of a second film fragment having a second functional material
that differs from the first functional material.

[0037]In various embodiments, the functional material may be a flavorant.
In certain oral care embodiments, a flavorant may be rapidly released as
the fragments disintegrate during use of the product, delivering a breath
freshening flavor, desired mouthfeel or sweetness into the oral cavity.
Useful flavorants may include synthetic flavor oils or a flavoring
aromatics, oleo resins and extracts derived from plants, leaves, flowers,
fruits and combinations thereof, as well as sweeteners. In certain
embodiments, the film comprises flavoring or food additive, such as those
described in Chemicals Used in Food Processing, publication 1274 by the
National Academy of Sciences, pages 63-258. In various embodiments, the
film comprises a flavorant at a level of about 0.01 to about 15%, about
0.1 to about 12%, or about 1 to about 10% by weight of the film.

[0038]In various embodiments, the film may comprise a therapeutic active.
As referred to herein, a "therapeutic active" is a material useful for
the prevention or treatment of a physiological disorder or condition.
Such disorders or conditions include those of the oral cavity (including
the teeth and gingiva), skin, hair, and eyes. The specific therapeutic
active is preferably determined according to the desired utility of the
composition. Such actives may include the following:

[0054]In various embodiments, the present invention provides a dentifrice
having suspended or embedded therein flakes of a water hydratable film
comprised of a mixture of a water soluble cellulosic polymer and a second
polymer having a solubility temperature lower than that of the first
polymer. In various embodiments, at least one of the first polymer or
second polymer is HPMC. In various embodiments, the first polymer is HPMC
and the second polymer is MC.

[0055]The films of the present invention may be made in a variety of ways,
including methods among those known in the art for making films. In
various embodiments, components of a film forming slurry, such as those
disclosed in the Examples below, are mixed to form a film forming slurry
composition. The slurry is cast on a releasable substrate and dried to
form a sheet of film material. In certain embodiments, the substrate
material has a surface tension that allows the film slurry to spread
substantially uniformly across the substrate surface, thereby avoiding
formation of a destructive bond between the Film and the substrate.
Non-limiting examples of suitable substrates include glass, stainless
steel, Teflon® and polyethylene- or silicone-impregnated paper.
Following casting, the film is then dried. Drying of the slurry can be
carried out at high temperature with the aid of a drying oven, a drying
terminal, a vacuum drier, or any other suitable drying equipment known in
the art. In other embodiments, the film is made by extrusion of the film
composition through a die, followed by cutting to a desired thickness,
and drying. In other embodiments, the film is made by solvent casting.

[0056]The films of the present invention may be made by formulation from a
slurry, where the dry film comprises the following:

[0057](a) about 5 to about 50% of the first polymer based on dry weight;
and

[0058](b) about 5 to about 50% of the second polymer, based on dry weight.

[0059]In various embodiments, the film comprises about 10 to about 40%,
about 12 to about 35%, and about 15 to about 30% of each of the first and
second polymers based on dry weight.

[0060]The film fragments may be incorporated in the base compositions of
the present invention at a broad range of concentrations. In various
embodiments, the carrier may comprise fragments at a level of about 0.005
to about 15%, about 0.01 to about 12%, about 0.05 to about 10%, about
0.01 to about 8% or about 0.05 to about 5% by weight of the composition.

[0061]In certain embodiments, the compositions of the present invention
comprise a film according to the present invention, in a carrier. As
referred to herein, a "carrier" is any material or composition in which a
film can be embedded and suspended, and is suitable for administration or
application to a human or animal subject as an oral care or personal care
formulation, or suitable for administration to a household surface as a
home care formulation. In various embodiments comprising a plurality of
film fragments, such fragments may be embedded, suspended dispersed or
otherwise distributed in the carrier. Selection of the carrier depends
upon the desired use of the film, i.e., in oral care, personal care or
home care compositions.

[0062]In various embodiments, the carrier is a liquid, semi-solid or
solid. A "liquid" can be a liquid of low or high viscosity, and includes
a liquid having a flowrate that is imperceptible under ambient
conditions. For example, a soap, such as a bar of hand soap, can be
considered a liquid as defined herein. A liquid can be a thixotropic
liquid. A "semi-solid" as used herein can be a gel, a colloid, or a gum.
As used herein, semi-solids and liquids are fluids distinguished on the
basis of viscosity: a semi-solid is a high viscosity fluid, while a
liquid has lower viscosity. There is no definitive dividing line between
these two types of fluids. A semi-solid can, in certain embodiments, have
a viscosity as high as thousands of mPas. Carriers useful herein include
liquids, pastes, ointments, gels, and foams, and can be transparent,
translucent or opaque.

[0064]In certain embodiments, a composition of the present invention can
be a skin care composition, for example, a soap, a lotion, a body wash, a
bath gel, a shampoo, a conditioner, a deodorant, an antiperspirant, a
fragrance, a perfume, a cosmetic or combinations thereof, such as a
antiperspirant/deodorant. In certain embodiments, a composition of the
present invention can be a hair care composition, such as, for example, a
shampoo or a conditioner, or a combination thereof.

[0065]In certain embodiments, a composition of the present invention can
be a home care composition, for example, a dishwashing detergent, a
laundry detergent, a fabric softener, a hard surface cleaner or a bleach
composition. Useful carriers for home care compositions include, for
example, surfactants, detergents and foaming agents.

[0066]The specific composition of the carrier preferably depends on the
intended use of the composition. In various embodiments, the carrier is
aqueous, comprising about 5 to about 95% water, about 10 to about 80%
water or about 15 to about 75% water. In other embodiments, the carrier
is substantially non-aqueous. In various embodiments, the carrier may be
a dentifrice carrier having a water content of about 5% to about 70%,
about 10% to about 50%, or about 20% to about 40%. In other embodiments,
the non-aqueous dentifrice carrier comprises less than about 5% water.

[0067]The carrier may comprise any of a variety of materials, including
emulsifiers, thickeners, fillers, and preservatives. In some embodiments,
the carrier comprises a functional material, such as those described
above. In some embodiments, the carrier comprises the same functional
material as the film.

[0068]In certain embodiments, the carrier is suitable for use as a
dentifrice. In some embodiments, the carrier comprises a humectant, such
as glycerine, sorbitol or an alkylene glycol such as polyethylene glycol
or propylene glycol. In some configurations, the carrier comprises a
humectant at a level of about 10% to about 80% by weight, or about 20% to
about 60% by weight of the composition. Carrier compositions among those
useful herein are disclosed in, e.g., U.S. Pat. No. 5,695,746 to Garlick,
Jr., et al, and U.S. Pat. No. 4,839,157 to Mei-King Ng et al.

[0069]In various dentifrice embodiments, the carrier comprises thickeners,
gelling agents or combinations thereof. Thickeners or gelling agents
useful herein include inorganic, natural or synthetic thickeners or
gelling agents. In some configurations, the carrier comprises the
thickener and gelling agent at total levels of about 0.10% to about 15%
by weight, or about 0.4% to about 10% by weight of the composition.
Examples of thickeners and gelling agents useful herein include inorganic
thickening silicas such as: an amorphous silica, for example Zeodent®
165 (Huber Corporation); Irish moss; iota-carrageenan; gum tragacanth; or
polyvinylpyrrolidone. In certain embodiments, the carrier comprises a
polishing agent, such as a silica, a calcined alumina, sodium
bicarbonate, calcium carbonate, dicalcium phosphate or calcium
pyrophosphate. In various embodiments, the carrier can be a visually
clear composition.

[0070]In certain dentifrice embodiments comprising a visually clear
carrier, the composition comprises at least one polishing agent.
Polishing agents among those useful herein include collodial silica, such
as, for example, Zeodent® 115 (Huber Corporation), and alkali metal
aluminosilicate complexes (i.e., a silica comprising alumina). In some
configurations, a polishing agent can have a refractive index close to
that of a gelling agent combined with water and/or humectant. In various
embodiments, the carrier comprises the polishing agent at a level of
about 5% to about 70% by weight of the composition.

[0071]In certain dentifrice embodiments, the carrier comprises a
surfactant or mixture of surfactants. Useful surfactants include
water-soluble salts of at least one higher fatty acid monoglyceride
monosulfate, such as the sodium salt of the monsulfated monoglyceride of
hydrogenated coconut oil fatty acids; cocamidopropyl betaine; a higher
alkyl sulfate such as sodium lauryl sulfate; an alkyl aryl sulfonate such
as sodium dodecyl benzene sulfonate; a higher alkyl sulfoacetate; sodium
lauryl sulfoacetate; a higher fatty acid ester of 1,2-dihydroxy propane
sulfonate; and a substantially saturated higher aliphatic acyl amides of
a lower aliphatic amino carboxylic acid, such as those having 12 to 16
carbons in the fatty acid, alkyl or acyl radicals; and mixtures thereof.
Amides can be, for example, N-lauroyl sarcosine, and the sodium,
potassium, and ethanolamine salts of N-lauroyl, N-myristoyl, or
N-palmitoyl sarcosine. In various embodiments the carrier comprises the
surfactant at a level of about 0.3 to about 15%, about 0.5% to about 10%,
or about 1 to about 3% by weight of composition.

[0072]In certain embodiments, water-insoluble polymeric materials can be
aqueous emulsions or dispersions of polymneric materials comprising
polymers. In some configurations, the polymers can comprise precursor
monomers, mixtures of monomers, natural polymers and mixtures thereof. In
some configurations, a polymeric material can also include
water-insoluble polymeric materials. In certain configurations, a
water-insoluble polymer can comprise about 3% to about 60%; about 4% to
about 40%, or about 5% to about 30% by weight of the composition. In
non-limiting example, a water-insoluble polymeric material can comprise
monomers chosen from aromatic vinyls, dienes, vinyl cyanides, vinyl
halides, vinylidene halides, vinyl esters, olefins and their isomers,
vinyl pyrrolidone, unsaturated carboxylic acids, alkyl esters of
unsaturated carboxylic acids, hydroxy derivatives of alkyl esters of
unsaturated carboxylic acids, amides of unsaturated carboxylic acids,
amine derivatives of unsaturated carboxylic acids, glycidyl derivatives
of alkyl esters of unsaturated carboxylic acids, olefinic diamines and
isomers, aromatic diamines, terephthaloyl halides, olefinic polyols and
mixtures thereof.

[0073]In various embodiments, a composition comprising a carrier and a
film fragment in accordance with the present invention can be suitable
for use as an antiperspirant, a deodorant, or an antiperspirant
/deodorant, a shampoo, a lotion.

Methods of Use:

[0074]In certain embodiments, the present invention provides methods for
the administering a film composition to a subject such as a human or
animal. As referred to herein, "administering" refers to any method by
which a composition is applied on or administered to the subject. In
various embodiments, the administration is topical, wherein the
composition is applied to an external surface of the subject, such as to
the oral surfaces (e.g., teeth, gums and tongue), to the skin, to the
eye, and to the hair. The specific route and method of administration
will depend upon the intended use of the composition.

[0075]In various embodiments, the present invention provides methods for
administering a functional material to a human or animal subject in need
thereof, comprising topically applying to said subject a composition
comprising a film in a carrier, wherein said film comprises the
functional material. In one embodiment, the method additionally comprises
disrupting the film after topically applying the film. Such disruption
may be accomplished by any of a variety of methods, including chemical
and/or mechanical means. Chemical means include degradation of the film
by contact with water or a material present at the site of administration
(e.g., saliva in an oral care application). Physical means include
agitation, grinding, and shear forces produced by application of physical
energy to the composition during use (e.g., brushing in a dentifrice
application or scrubbing or wiping in a home care application).

[0076]In various embodiments, the present invention provides methods for
the treatment of an oral care condition. As referred to herein, an "oral
care condition" is any disorder or condition that can be prevented or
treated by administration of a composition to the oral cavity, including
disorders or conditions of the teeth, oral mucosa, gingiva and tongue.
Such conditions include caries, gingivitis, periodontist, sensitivity,
dry mouth, buildup of calculus and cosmetic conditions such as staining,
loss of tooth enamel or malodor.

[0077]In certain embodiments, the present invention provides methods for
maintaining the systemic health of a mammal, comprising the steps of
administering to the mammal a composition comprising a film according to
the present invention.

[0078]The present invention can be further understood by reference to the
following non-limiting Examples.

EXAMPLES

[0079]Various slurries were prepared in accordance with Table 1, with
varying proportions of methylcellulose (MC) and
hydroxypropylmethylcellulose (HPMC), as follows:

[0080]The slurries were then cast into films, which were then tested to
determine various physical characteristics. Stability of the films in a
dentifrice carrier was evaluated after 1 week at controlled room
temperature by: (1) visual determination that no change in shape or size
occurred; and (2) tactile determination that shapes did not break apart
with gentle rubbing. The specific dentifrice used in this evaluation was
prepared using ingredients and methods known in the art, but specifically
containing 2% organic acid polymer, e.g., polyvinylalkyl ether-maleic
acid copolymer for example, Gantrez®). Results of the tests are shown
below: